Invanz Side Effects

Generic name: ertapenem

Note: This document contains side effect information about ertapenem. Some of the dosage forms listed on this page may not apply to the brand name Invanz.

Some side effects of Invanz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ertapenem: injectable powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking ertapenem (the active ingredient contained in Invanz) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fever;

• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

• loss of balance or coordination, trouble walking;

• tremors, twitching, or rigid (very stiff) muscles;

• seizures (black-out or convulsions); or

• diarrhea that is watery or bloody.

Less serious side effects of ertapenem may include:

• mild nausea or diarrhea, constipation;

• vaginal itching or discharge;

• headache; or

• pain, redness, or mild swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ertapenem: injectable powder for injection

General

In general, the most common side effects associated with ertapenem (the active ingredient contained in Invanz) have been considered mild to moderate and have included diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), vaginitis in females (2.1%), phlebitis/thrombophlebitis (1.3%), and vomiting (1.1%).

Local

Local side effects have included infused vein complication (up to 7.1%), extravasation (up to 1.9%), and phlebitis/thrombophlebitis (up to 1.9%). Injection site induration and injection site pain have been reported in greater than 0.1% of patients. Tenderness and ecchymosis have also been reported.

Nervous system

In clinical trials, seizures were reported in 0.5% of patients. Patients with end-stage renal disease may be at a greater risk of developing seizures. A case report describes a patient on continuous ambulatory peritoneal dialysis who had multiple tonic-clonic seizures after receiving 2 doses of ertapenem (the active ingredient contained in Invanz)

Nervous system side effects have included headache (up to 6.8%), altered mental status (includes agitation, confusion, disorientation, decreased mental acuity, changed mental status, somnolence, stupor; up to 5.1%), insomnia (3.2%), and dizziness (up to 2.1%). Syncope, seizure, tremor, hypesthesia, spasm, paresthesia, and vertigo have been reported in greater than 0.1% of patients. Cerebrovascular accident (greater than 0.5% and less than 1%) has been reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery. Hallucinations, coordination abnormal, dyskinesia, gait disturbance, myoclonus, and tremor have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 10.3%), nausea (up to 8.5%), abdominal pain (up to 4.3%), constipation (up to 4%), vomiting (up to 4%), acid regurgitation (up to 1.6%), dyspepsia (up to 1.1%), and oral candidiasis (up to 1.4%). Gastrointestinal hemorrhage, anorexia, flatulence, Clostridium difficile associated diarrhea, stomatitis, dysphagia, hemorrhoids, ileus, cholelithiasis, duodenitis, esophagitis, gastritis, jaundice, mouth ulcer, pancreatitis, pyloric stenosis, and taste perversion have been reported in greater than 0.1% of patients. Small intestinal obstruction (2.1%), C difficile infection or colitis (1.7%), dry mouth (greater than 0.5% and less than 1%), and hematochezia (greater than 0.5% and less than 1%) have been reported in a study using 1 g of ertapenem (the active ingredient contained in Invanz) for prophylaxis of surgical site infection following elective colorectal surgery.

Cardiovascular

Cardiovascular side effects have included chest pain (up to 1.5%), hypotension (up to 2%), hypertension (up to 1.6%), and tachycardia (up to 1.6%). Heart failure, hematoma, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, and subdural hemorrhage have been reported in greater than 0.1% of patients.

Respiratory

Respiratory side effects have included dyspnea (up to 2.6%), cough (up to 1.6%), pharyngitis (up to 1.1%), rales/rhonchi (up to 1.1%), and respiratory distress (up to 1%). Pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, and voice disturbance have been reported in greater than 0.1% of patients. Pneumonia (2.1%) and atelectasis (3.4%) have been reported in a study using 1 g of ertapenem (the active ingredient contained in Invanz) for prophylaxis of surgical site infection following elective colorectal surgery. Lung crackles, lung infiltration, pulmonary congestion, pulmonary embolism, and wheezing have been reported in greater than 0.5% and less than 1% of patients in the prophylaxis study.

Dermatologic

Dermatologic side effects have included rash (up to 2.5%), pruritus (up to 2%), and erythema (up to 1.6%). Sweating, dermatitis, desquamation, and urticaria have been reported in greater than 0.1% of patients. Cellulitis (1.5%) has been reported in a study using 1 g of ertapenem (the active ingredient contained in Invanz) for prophylaxis of surgical site infection following elective colorectal surgery. Drug rash with eosinophilia and systemic symptoms (DRESS syndrome) has been reported during postmarketing experience.

Hematologic

Hematologic side effects have included increased platelet count (up to 6.5%), decreased hemoglobin (up to 4.9%), decreased hematocrit (up to 3.4%), increased eosinophils (up to 2.1%), decreased segmented neutrophils (up to 1.5%), increased prothrombin time (up to 1.2%), decreased platelet count (1.1%), and decreased WBCs (up to 1.5%). Increased monocytes and PTT have been reported in greater than 0.1% and less than 1% of patients. Anemia (5.7%) and increased white blood cell count (greater than 1%) have been reported in a study using 1 g of ertapenem (the active ingredient contained in Invanz) for prophylaxis of surgical site infection following elective colorectal surgery.

Genitourinary

Genitourinary side effects have included vaginitis (up to 3.3%), increased urine RBCs (up to 2.5%), increased urine WBCs (up to 2.5%), and increased urine epithelial cells (greater than 0.1% and less than 1%). Oliguria/anuria, vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, and vulvovaginitis have been reported in greater than 0.1% of patients. Urinary tract infection (3.8%), dysuria (1.1%), presence of urine protein (greater than 1%), and pollakiuria (greater than 0.5% and less than 1%) have been reported in a study using 1 g of ertapenem (the active ingredient contained in Invanz) for prophylaxis of surgical site infection following elective colorectal surgery.

Hepatic

Hepatic side effects have included increased ALT (up to 8.8%), AST (up to 8.4%), and alkaline phosphatase (up to 6.6%).

Other

In clinical trials, death occurred in 1.6% of all patients (n=1954). In patients with intraabdominal infections, death occurred in 4.7% (n=316) of patients receiving ertapenem (the active ingredient contained in Invanz) however, these were considered not drug-related.

Other side effects have included fever (up to 5%), edema/swelling (up to 3.4%), death (up to 2.5%), asthenia/fatigue (1.2%), and leg pain (up to 1.1%). Abdominal distention, pain, chills, septicemia, septic shock, malaise, necrosis, candidiasis, facial edema, flank pain, and flushing have been reported in greater than 0.1% of patients. Postoperative infection (2.3%), wound infection (6.5%), anastomotic leak (1.5%), seroma (1.3%), wound complication (2.9%), wound dehiscence (1.3%), and wound secretion (1.9%) have been reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery. Crepitations, abdominal abscess, fungal rash, pelvic abscess, incision site complication, incision site hemorrhage, and intestinal stoma complication have been reported in greater than 0.5% and less than 1% of patients in the prophylaxis study.

Metabolic

Metabolic side effects have included decreased serum potassium (up to 1.8%), decreased serum albumin (up to 1.7%), increased serum glucose (up to 1.7%), increased serum bilirubin (up to 1.7%), increased serum potassium (up to 1.3%), dehydration (greater than 0.1%), and weight loss (greater than 0.1%). Increased direct and indirect serum bilirubin, increased serum sodium, and decreased serum bicarbonate have been reported in greater than 0.1% and less than 1% of patients.

Psychiatric

Psychiatric side effects have included anxiety (up to 1.4%). Nervousness, depression, and aggressive behavior have been reported in greater than 0.1% of patients. Altered mental status (including aggression, delirium) has been reported during postmarketing experience.

Renal

Renal side effects have included increased serum creatinine (up to 1.1%), renal insufficiency/impairment (greater than 0.1%), and increased BUN (greater than 0.1% and less than 1%).

Musculoskeletal

Musculoskeletal side effects have included gout (greater than 0.1%). Muscle spasms (greater than 0.5% and less than 1%) have been reported in a study using 1 g of ertapenem (the active ingredient contained in Invanz) for prophylaxis of surgical site infection following elective colorectal surgery. Muscular weakness has been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis (including anaphylactoid reactions) during postmarketing experience.

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